Combination therapy with a long-acting beta-agonist and a leukotriene antagonist in moderate asthma.


Journal Article

Long-acting beta-agonists (LABAs) and inhaled corticosteroids administered together appear to be complementary in terms of effects on asthma control. The elements of asthma control achieved by LABAs (improved lung function) and leukotriene receptor antagonists (LTRAs; protection against exacerbations) may be complementary as well.We sought to determine whether the combination of the LTRA montelukast and the LABA salmeterol could provide an effective therapeutic strategy for asthma.In a randomized, placebo-controlled, crossover study of 192 subjects with moderate asthma, we compared the clinical efficacy of regular treatment over 14 weeks with the combination of montelukast and salmeterol to that with the combination of beclomethasone and salmeterol in moderate asthma. The primary efficacy outcome was time to treatment failure.Three months after the randomization of the last subject, the Data and Safety Monitoring Board determined that the primary research question had been answered and terminated the trial. The combination of montelukast and salmeterol was inferior to the combination of beclomethasone and salmeterol as judged by protection against asthma treatment failures (p = 0.0008), lung function (26 L/min difference in a.m. peak expiratory flow rate, p = 0.011), asthma control score (0.22 difference in Asthma Control Questionnaire score, p = 0.038), and markers of inflammation and airway reactivity.Patients with moderate asthma similar to those we studied should not substitute the combination of an LTRA and an LABA for the combination of inhaled corticosteroid and an LABA.

Full Text

Cited Authors

  • Deykin, A; Wechsler, ME; Boushey, HA; Chinchilli, VM; Kunselman, SJ; Craig, TJ; DiMango, E; Fahy, JV; Kraft, M; Leone, F; Lazarus, SC; Lemanske, RF; Martin, RJ; Pesola, GR; Peters, SP; Sorkness, CA; Szefler, SJ; Israel, E; National Heart, Lung, and Blood Institute's Asthma Clinical Research Network,

Published Date

  • February 2007

Published In

Volume / Issue

  • 175 / 3

Start / End Page

  • 228 - 234

PubMed ID

  • 16973987

Pubmed Central ID

  • 16973987

Electronic International Standard Serial Number (EISSN)

  • 1535-4970

International Standard Serial Number (ISSN)

  • 1073-449X

Digital Object Identifier (DOI)

  • 10.1164/rccm.200601-112oc


  • eng